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The dS FootAnkle Coil 8ch 1.5T is intended to be used in conjunction with Philips Magnetic Resonance Scanner to produce diagnostic images of the foot and ankle that can be interpreted by a trained physician.

The dS FootAnkle Coil 8ch 1.5T is a phased-array, receive-only coil with rigid volume consisting of 8 elements. This coil is a ski-boot-shaped coil designed for optimum coverage and highresolution visualization of the ankle and entire foot down to the toes. The coil design and element lavout allow for either large field of view (FOV) imaging of the whole foot or small FOV high resolution imaging of ankle joints. The coil is easy to set up and can be used with the patient's foot positioned vertically. These coils are used independently and cannot be combined with any other coils and are available for 1.5T Prodiva/ MR 5300 MR Systems.

The provided text is a 510(k) summary for the dS FootAnkle Coil 8ch 1.5T. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving that an AI/software device meets specific performance acceptance criteria through a clinical study.

Therefore, many of the specific details requested in your query (e.g., acceptance criteria for diagnostic algorithm performance, multi-reader multi-case studies, ground truth establishment methods for training sets of AI, sample sizes for AI test/training sets, adjudication methods) are not present in this document because the device in question is an MR coil, not an AI diagnostic software.

However, I can extract information related to the performance testing that was performed to support the substantial equivalence of the MR coil.

Here's what can be gathered from the provided text, with explanations where information is not applicable:

Acceptance Criteria and Device Performance for the dS FootAnkle Coil 8ch 1.5T

This document describes the regulatory submission for an MR coil, not an AI diagnostic software. As such, the "acceptance criteria" and "device performance" are related to the physical and imaging characteristics of the coil, not the diagnostic performance of an AI algorithm. The study described is a demonstration of equivalence and image quality for an MR coil.

1. Table of Acceptance Criteria and Reported Device Performance

The document references two FDA guidance documents for performance criteria:

• "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, issued November 18, 2016" (General MR Device Guidance)
• "Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway, issued December 11, 2020" (Specific Coil Performance Guidance)

While the specific numerical acceptance criteria from these guidances are not explicitly listed in the 510(k) summary, the document states that the device "met all criterion in the guidance" and that "No new safety or efficacy concerns are raised".

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact number of cases or images used for the "Clinical Performance" assessment. It only states "Acquired Image quality was assessed..." The extent of this "assessment" (e.g., number of patients/scans reviewed) is not detailed.
• Data Provenance: Not explicitly stated (e.g., specific country, retrospective/prospective). However, the experts used were "U.S. Board Certified radiologists," suggesting data consistent with US clinical practice.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Two
• Qualifications: "U.S. Board Certified radiologists." No specific years of experience are mentioned.

4. Adjudication Method for the Test Set

• Not applicable/Not described. The assessment was to "confirm images produced on the subject coil are sufficient quality for diagnostic use," implying a qualitative assessment by the two radiologists, rather than a quantifiable "ground truth" establishment requiring adjudication for diagnostic accuracy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This was not an MRMC study comparing human readers with and without AI assistance. It was an assessment of image quality from an MR coil by two readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This is an MR coil, not a standalone algorithm. The performance is inherently linked to the image acquisition process.

7. The Type of Ground Truth Used

• For the "clinical performance," the "ground truth" was the qualitative assessment by two U.S. Board Certified radiologists that the "images produced on the subject coil are sufficient quality for diagnostic use." This is not a diagnostic "ground truth" for disease presence, but rather a performance "ground truth" for image utility.

8. The Sample Size for the Training Set

• Not Applicable. This is an MR coil, not an AI device that undergoes training.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As above, this is an MR coil, not an AI device.

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